Interventional Effects on Myocardial Revascularization Post-surgical Patients

NCT04790656 | Completed

• 1 other identifier: REC/00874 Arjumand Bano
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

The aim is to evaluate the effectiveness of physical exercise on a cycle ergometer combine with CPAP in the postoperative period after myocardial revascularization

Conditions

Myocardial Revascularization

Outcome Measures

Primary Outcomes (4)

• Modified Borg scale

  The Modified Borg Dyspnoea Scale is most commonly used to assess symptoms of breathlessness. Despite being a subjective measure of exercise intensity, RPE scales provide valuable information when used correctly.

  4th day

• 6 min walk distance

  The six minute walking test (6MWT) was developed by the American Thoracic Society and it was officially introduced in 2002, coming along with a comprehensive guideline. The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity

  4th day

• 1 min sit to stand test

  Vaidya et al reported that 1-minute STS test is a simple and sensitive test and appears to be a practical, reliable, valid, and responsive alternative for measuring exercise capacity, particularly where space and time are limited

  4th day

• Digital Monovacumeter

  The manovacuometer is a simple, quick and non-invasive test which measures the maximal respiratory pressures (MRS).Digital manovacuometer is a reliable and valid instrument for assessing maximum inspiratory pressure and maximum expiratory pressure in healthy subjects

  4th day

Study Arms (2)

Conventional Therapy

ACTIVE COMPARATOR

The control program will consist of progressive exercises according to each postoperative day. Two daily sessions with an average duration of 25 min will be performed. In addition to the physiotherapeutic program standardized by the hospital's team of physical therapists, the intervention group will perform physical exercise on a cycle ergometer with CPAP.

Other: Conventional Therapy

Cycle ergometer combine with CPAP

EXPERIMENTAL

Physical exercise on a cycle ergometer combine with CPAP will be performed in a single daily session from the second to the fourth postoperative days

Other: Cycle ergometer combine with CPAP

Interventions

Conventional Therapy OTHER

Subjects will randomly placed into intervention group and control group . In addition to the physiotherapeutic program standardized by the hospital's team of physical therapists, the intervention group will perform physical exercise on a cycle ergometer with CPAP.

Conventional Therapy

Cycle ergometer combine with CPAP OTHER

Physical exercise on a cycle ergometer combine with CPAP will be performed in a single daily session from the second to the fourth postoperative days . The maximum exercise time for postoperative day 2 will be 20 min, and 30 min for the third and fourth postoperative days.

Cycle ergometer combine with CPAP

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who have undergone myocardial revascularization surgery
• An ejection fraction of greater than40%
• Post operative mechanical ventilation for \<12hours
• No definite diagnosis of chronic obstructive pulmonary disease and asthma

You may not qualify if:

• With complications in post operative period (e.g., Artial fibrillation, prolonged mechanical ventilation)
• Hemodynamically unstable patients
• Intolerance to CPAP(continuous positive airway)mask

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Rawalpindi institute of cardiology

Rawalpindi, Punjab Province, 43600, Pakistan

Location

Study Officials

• Anam Aftab, Phd*

  Riphah college of rehabilitation and allied health sciences - Rawalpindi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2021
• First Posted: March 10, 2021
• Study Start: October 14, 2020
• Primary Completion: August 20, 2021
• Study Completion: August 20, 2021
• Last Updated: September 23, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)